MAUDE Adverse Event Report: DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number 00514010200

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).The product will not be returned to zimmer biomet.Product is being evaluated by external contractor.Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the unit had a burning smell, and the touch screen was not responsive.The event timing was before surgery.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The previous repair record for intellicart system serial number 1160060 was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair record review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using crm to query for serial number (b)(4), the device was noted to have been previously repaired 4 times, the previous repair being for vacuum sensor errors on 29 august 2019.The vacuum pump is not associated with the current repair.Thus, this repair was a non-related issue.On 4 september 2019, it was reported from (b)(6) hospital that the unit had a burning smell and the touch screen was not responsive.On 4 september 2019, a zimmer biomet certified service repair technician was contacted about the cart and was dispatched to be at the site.On 5 september 2019, the technician arrived at the site, evaluated the device, and was unable to duplicate a concern regarding the monitor; however, he confirmed a smell like hot plastic emanating from the unit.He replaced the vacuum pump.The unit was run continuously but the smell persisted.On 12 september 2019, the technician replaced the control board and power supply but noted no improvement.The technician was unable to find any issues and had an exchange unit prepared.A new cart (serial #1590162) was shipped from riverside on 12 september 2019, and the replacement cart was noted to be delivered on 16 september 2019.A service technician was dispatched to the site to perform the exchange.On 23 september 2019, the service technician confirmed that the exchange was completed and that the exchanged unit was packaged and ready for return.The exchange cart was picked up from the facility on 23 september 2019 and was confirmed that it was returned to riverside on 27 september 2019.The cart was refurbished as noted in crm with new serial number #(b)(4).Service work order (b)(4) on 4 september 2019.The reported event of the touch screen not responding could not be confirmed and the reported event for an odor from the unit was confirmed during inspection of the device; however, the root cause could not be determined and the device was replaced and refurbished as a result.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 9079130
• MDR Text Key: 199709625
• Report Number: 0001954182-2019-00058
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00514010200
• Device Lot Number: 0023808
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1